Hadley, Kevin et al.

Patent Trials and Appeals Board

Mar 5, 2020

12904049 - (D) (P.T.A.B. Mar. 5, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/904,049 10/13/2010 Kevin Hadley 28696-US-NP 5142
109143 7590 03/05/2020
DSM North America Inc.
Patent Department
6480 Dobbin Road
Columbia, MD 21045
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
03/05/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
dsm_PAIR@firsttofile.com
dsmna.ip@dsm.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KEVIN HADLEY, TERENCE FEALEY, and JULIAN E. BAILES
____________

Appeal 2019-003808
Application 12/904,049
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to a
method for reducing the risk of pathological effects of traumatic brain
injury. The Examiner rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as DSM IP
Assets, B.V. (see Appeal Br. 3).
2 We have considered and herein refer to the Specification of Oct. 13, 2010
(“Spec.”); Final Office Action of Sep. 13, 2017 (“Final Act.”); Appeal Brief
of Oct. 15, 2018 (“Appeal Br.”); and Examiner’s Answer of Feb. 12, 2019
(“Ans.”).
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Statement of the Case
Background
“Traumatic brain injury (TBI) is a head injury caused by trauma to the
brain” (Spec. ¶ 2). “Following a traumatic injury to the central nervous
system (CNS), a cascade of physiological events can lead to neuronal loss
including, for example, an inflammatory immune response and
excitotoxicity resulting from the initial impact disrupting the glutamate,
acetylcholine, cholinergic, [γ-aminobutyric acid (GABAA)], and [N-methyl-
D-aspartate (NMDA)] receptor systems” (Spec. ¶ 3). “Treatment[s] of
traumatic brain injury have included diuretics, anti-convulsants, and [α-
amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)]/NMDA
receptor antagonists. However, it is desirable to have treatments that can
provide a prophylactic neuroprotective effect that can reduce the risk of
neurological damage associated with traumatic brain injury” (Spec. ¶ 7).
“The present disclosure provides a method for prophylactic treatment
that reduces the risk of pathological effects associated with traumatic brain
injury” (Spec. ¶ 8). The method involves administering “a composition
comprising [docosahexaenoate (DHA)] . . . to a subject at risk for traumatic
brain injury prior to the subject engaging in an activity associated with a risk
of traumatic brain injury” (id.). DHA “refers to (all-Z)-4,7,10,13,16,19-
docosahexaenoic acid, as well as any salts or derivatives thereof. Thus, the
term [DHA] encompasses the free acid DHA as well as DHA alkyl esters
and triglycerides containing DHA” (Spec. ¶ 40).
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The Claims
Claims 1, 3–7, 18, 22–27, 29, 33–35, and 37–40 are on appeal.3
Independent claim 1 is representative and reads as follows:
1. A method for reducing the risk of pathological effects of
traumatic brain injury in a human subject, the method
comprising:

administering to the subject who is engaged in an activity
associated with a known risk of traumatic brain injury,

wherein the activity is selected from the group consisting of
boxing, football, soccer, hockey, armed conflict, or brain
surgery,

a composition comprising docosahexaenoate (DHA) in an
amount of at least about 65 wt% and less than 99 wt.% of the
total fatty acid content of the composition,

wherein the composition is administered prior to engagement in
the activity associated with a risk of traumatic brain injury to
reduce the risk of pathological effects of traumatic brain injury,

wherein the composition has an eicosapentaenoate (EPA)
content of less than about 2 wt% of the total fatty acid content
of the composition, and the DHA to EPA ratio is at least
100:1.

(Appeal Br. 11).

3 Claims 2, 8–17, 19–21, 28, 30–32, and 36 were cancelled (See Appeal Br.
11–13).
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The issues
A. The Examiner rejected claims 1, 18, 22, 23, 25, and 39 under 35
U.S.C. § 103(a) as obvious over Wu,4 Farooqui,5 Lyden,6 and Romano,7
(Final Act. 4–7).
B. The Examiner rejected claims 3–7, 26, 27, and 35 under 35 U.S.C.
§ 103(a) as obvious over Wu, Farooqui, Lyden, Romano, and Groenendijk8
(Final Act. 7–8).
C. The Examiner rejected claims 24, 29, 33, 34, and 40 under 35 U.S.C.
§ 103(a) as obvious over Wu, Farooqui, Lyden, Romano, and Barnes9 (Final
Act. 8–12).
D. The Examiner rejected claims 37 and 38 under 35 U.S.C. § 103(a) as
obvious over Wu, Farooqui, Lyden, Romano, Barnes, and Groenendijk
(Final Act. 12–13).
A. 35 U.S.C. § 103(a) over Wu, Farooqui, Lyden, and Romano
The Examiner finds Wu teaches that orally administering a fish oil
composition containing equal amounts DHA and eicosapentaenoic acid
(EPA) to rats for 28 days before subjecting the rats to traumatic brain injury
was effective in reducing the risk of pathological effects of traumatic brain
injury (Final Act. 4). The Examiner finds that one skilled in the art would

4 Wu, A. et al., Dietary Omega-3 Fatty Acids Normalize BDNF Levels,
Reduce Oxidative Damage, and Counteract Learning Disability after
Traumatic Brain Injury in Rats, 21 J. NEUROTRAUMA 1457–1467 (2004).
5 Farooqui, A. A. et al., Modulation of inflammation in brain: a matter of fat,
101 J. NEUROCHEMISTRY 577–599 (2007).
6 Lyden, US 2002/0188997 A1, published Dec. 19, 2002.
7 Romano, US 2005/0215571 A1, published Sept. 29, 2005.
8 Groenendijk et al., WO 2009/057994 A1, published May 7, 2009.
9 Barnes et al., US 5,506,211, issued Apr. 9, 1996.
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have been able “to optimize this period of time in order to attain the best
treatment for a particular human patient,” including 6 weeks of pre-treatment
(id. at 6–7). The Examiner finds Wu teaches “it is likely that the beneficial
effects of fish oil supplementation are attributable to DHA” (id. at 4). The
Examiner finds Farooqui teaches “based on recent literature, the dietary
intake of food rich DHA can decrease or prevent inflammatory processes in
the brain tissue and can be beneficial for the neuroinflammation associated
with acute neural trauma and neurodegenerative diseases” (id. at 5).
The Examiner acknowledges that neither Wu nor Farooqui teach “that
the subjects who are engaged in an activity that is associated with a risk of
TBI are selected from the group consisting of boxing, football, soccer, etc.”
(id.). The Examiner finds Lyden and Romano teach traumatic brain injury
may be caused by sports injuries, including repeated heading of the soccer
ball (id.). The Examiner determines
[I]t would have been prima facie obvious for a person of
ordinary skill in the art to administer pure DHA or almost pure
DHA, instead of a mixture of DHA and EPA, to individuals at
risk of suffering TBI, like individuals engaged in sports like
soccer, before they engage in such activity that is associated
with a risk of TBI, since the prior art teaches that the activity
observed with the mixture of DHA and EPA is more likely to
be concentrated in DHA and not EPA.

(id. at 5–6).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Wu, Farooqui, Lyden, Romano,
Barnes, and Groenendijk render the claims obvious?
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Findings of Fact (“FF”)
1. Wu teaches that “[t]raumatic brain injury (TBI) is a major cause
of disability such that a great concern exists to develop means to decrease its
short- and long term effects” (Wu 1457).
2. Wu teaches an experiment to assess “whether omega-3 fatty
acids in the diet can provide protection against learning impairment [in rats]
after TBI” (Wu 1460).
3. Wu teaches feeding rats a diet containing 8% fish oil (12.4%
DHA and 13.5% EPA) for a total of 4 weeks. The rats were exposed to TBI
by “mild fluid percussion injury (FPI).” The rats were given the same diet
for 1 week post injury (Wu 1458).
4. Wu teaches the experimental results demonstrated that “TBI
rats fed the FO supplemented diet showed significant improvement in their
learning ability,” similar to that of rats which did not receive TBI, and unlike
rats with a regular diet that received TBI (Wu 1460).
5. Wu teaches that the findings “suggest that omega-3 fatty acid-
enriched dietary supplements can be a potent therapeutic agent for reducing
the deleterious effects of TBI on synaptic plasticity and cognition” (Wu
1461).
6. Wu teaches “[a]lthough the major components of FO in our
study are DHA and EPA, it is likely that the beneficial effects of FO
supplementation are attributable to DHA. . . . However, a direct link between
DHA and the observed findings in our study need to be further investigated
by using pure DHA in the diet” (Wu 1463–1464).
7. Farooqui teaches that fish oil supplements containing EPA and
DHA can reduce neuroinflammation (Farooqui 589–590).
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8. Farooqui teaches “[n]euroinflammation is an active defensive
process against diverse insults [including] metabolic and traumatic injuries”
(Farooqui 592).
9. Lyden teaches “soccer players are at risk of chronic traumatic
brain injury due to repeated heading of the soccer ball. The cumulative
trauma has a degenerative effect similar to that which has been observed in
boxers” (Lyden ¶ 5).
10. Romano teaches “cognitive impairments caused by traumatic
brain injuries” include “traumas to the head, such as, for example, traumas
caused by accidents and/or sports injuries” (Romano ¶ 49).

Principles of Law
“Obviousness does not require absolute predictability of success . . .
all that is required is a reasonable expectation of success.” In re Kubin, 561
F.3d 1351, 1360 (Fed. Cir. 2009).

Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 4–7; FF 1–10) and agree that
the claims are rendered obvious by Wu, Farooqui, Lyden, and Romano. We
address Appellant’s arguments below.
Appellant contends “Wu does not teach or suggest DHA in an amount
of at least about 65 wt.% and less than 99 wt.% of the total fatty acid
composition” (Appeal Br. 5). Appellant contends Wu does not teach or
suggest “a pure or 100% DHA mixture” (id.). Rather, “[t]he DHA in the
diet of Wu is in an amount of 12.4%, which is a percentage of the fish oil”
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(id.). Appellant contends therefore, that “[t]here was no expectation that the
use of DHA alone would be successful based on Wu” (id. at 6).
We are not persuaded. Wu suggests that “it is likely that the
beneficial effects of fish oil supplementation are attributable to DHA” (FF
6). We agree with the Examiner that “the prior art offers a very strong
motivation to repeat Wu’s experiments, but administering only DHA
(instead of a mixture of DHA and EPA), or mainly DHA, since both Wu and
Farooqui suggest and/or teach that DHA is likely responsible for the efficacy
in treating or decreasing the risk of TBI” (Ans. 15). A discovery that
“proved conclusively what was strongly suspected before,” even though it
“may have significantly advanced the state of the science,” is not “inventive
in nature.” Therefore, inventions based on that discovery are unpatentable
under § 103. Pharmastem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342,
1363–1364 (Fed. Cir. 2007). “Scientific confirmation of what was already
believed to be true may be a valuable contribution, but it does not give rise
to a patentable invention.” Id. See, e.g., Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015) (“[M]erely routine
optimization of drug dosage to maximize therapeutic effect.”)
Appellant contends that “Wu discloses feeding a diet having 0.9%
DHA and 0.1 % EPA following injury; see, p. 1458, ‘[a]fter consumption of
the same diet for 1 week post-injury’” (Appeal Br. 5–6). Appellant contends
“[i]t is not possible to conclude in Wu that pre-injury treatment alone would
actually be efficacious as Wu disclosed administration of a composition both
pre- and post-injury” (id. at 6). Appellant contends:
One of skill in the art would not look to Wu for reducing risks
associated with traumatic brain injury by administration of a
composition comprising DHA prior to engagement in an
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activity associated with a risk of traumatic brain injury, as Wu
includes continuous feeding of DHA and EPA post-injury and
neuroprotection could just as easily have been attributed to
treatment post-injury w/DHA or EPA based upon the study
design.

(id.).
We are not persuaded. Wu teaches administering omega-3 fatty acids
to protect against TBI-induced learning impairment (FF 2). Therefore, Wu
teaches pre-injury treatment. Moreover, we agree with the Examiner that
“the instant claims do not exclude other steps to be performed like . . . the
administration of DHA after the TBI occurs” (Ans. 17). See Invitrogen
Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The
transition ‘comprising’ in a method claim indicates that the claim is open-
ended and allows for additional steps”). Because the claims do not exclude
continued treatment after TBI, Appellant’s arguments do not distinguish the
combination of Wu, Farooqui, Lyden, and Romano.
Appellant separately argues dependent claim 23 (Appeal Br. 7).
Appellant contends that treatment for 6 weeks is distinguishable from Wu’s
teaching of 4 weeks, in that “6 weeks is a 50% increase over 4 weeks” (id.).
Appellant contends “[t]he claimed amount in the present application and the
amount disclosed in Wu are not close enough that one skilled in the art
would have expected them to have the same properties” (id.).
We do not agree. “The law is replete with cases in which the
difference between the claimed invention and the prior art is some range or
other variable within the claims. These cases have consistently held that in
such a situation, the applicant must show that the particular range is critical,
generally by showing that the claimed range achieves unexpected results
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relative to the prior art range.” In re Woodruff, 919 F. 2d 1575, 1578, 16
USPQ2d 1934, 1936 (Fed. Cir. 1990). Appellant has provided no evidence
showing the criticality of the claimed 6 week treatment. “[A]ttorney
argument [is] not the kind of factual evidence that is required to rebut a
prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997). Rather, the evidence in the Specification describes the same 28
day pre-treatment as the prior art (see Spec. ¶ 174).

Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that Wu, Farooqui, Lyden, and Romano render the claims
obvious.

B–D. 35 U.S.C. § 103(a) over Wu, Farooqui, Lyden, Romano, Groenendijk
and Barnes
Appellant does not separately argue these obviousness rejections,
instead relying upon their arguments to overcome the combination of Wu,
Farooqui, Lyden, and Romano (see Appeal Br. 7–10). Having affirmed the
obviousness of claims 1, 18, 22, 23, 25, and 39 for the reasons given above
over Wu, Farooqui, Lyden, and Romano, we also find that the further
combinations with Groenendijk and Barnes render the rejected claims
obvious for the reasons given by the Examiner (see Final Act. 7–17).

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DECISION

In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 18, 22,
23, 25, 39
103(a) Wu, Farooqui, Lyden,
Romano
1, 18, 22,
23, 25, 39

3–7, 26,
27, 35
103(a) Wu, Farooqui, Lyden,
Romano, Groenendijk
3–7, 26, 27,
35

24, 29, 33,
34, 40
103(a) Wu, Farooqui, Lyden,
Romano, Barnes
24, 29, 33,
34, 40

37, 38 103(a) Wu, Farooqui, Lyden,
Romano, Groenendijk,
Barnes
37, 38
Overall
Outcome
1, 3–7, 18,
22–27, 29,
33–35, 37–
40

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED